ValidationNCT06805435
Is Continuous Non-Invasive Monitoring Accurate When Used on the Lower Extremity: Finger Vs Toe?
An observational study of Validation and Blood Pressure, run by Riverside University Health System Medical Center at 1 site in United States.
Trial summary
The goal of this observational study is to assess the validity of a continuous non-invasive blood pressure monitoring device, Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA), when used on the toe in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Validation, Blood Pressure, Device
- What is being tested?
- Continuous non-invasive blood pressure monitoring
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2025to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consistent of a convenience sample of available healthy volunteer medical students or residents.
Who may be able to join
- 18 years or older
- Medical student or resident
Who cannot join
- Medical history of Raynaud's or peripheral vascular disease
- Allergy to adhesive
Trial locations and contacts
1 site in 1 country.
United States1 site
Riverside University Health System Medical Center
Moreno Valley, California, 92555
About this study
Official title: Is Continuous Non-Invasive Monitoring Accurate When Used on the Lower Extremity?: a Pilot Study
The goal of this observational study is to assess the validity of a continuous non-invasive blood pressure monitoring device, Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA), when used on the toe in healthy volunteers. The main questions it aims to answer is:
- Can a continuous non-invasive blood pressure monitoring device accurately measure hemodynamic parameters when placed on a toe as compared to the finger in a healthy volunteer?
Read more
Secondary Outcomes:
- What are the effects of length and circumference of the middle phalanx of the 2nd toe on the accuracy of the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) measurements compared to the measurements taken from the finger?
- What are the effects of a Valsalva maneuver on the measurements taken from the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) on a toe compared to the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) placed on the finger.
Participants will:
- Have blood pressures taken using an automatic blood pressure cuff (both arms and both calves)
- Have a continuous non-invasive blood pressure monitoring sensor placed on their finger and toe simultaneously for 10 minutes
- Be asked to valsalva briefly to induce a change in blood pressure to be observed by the dual sensors
Read the detailed description
For each volunteer the investigators will measure the length from the proximal interphalangeal (PIP) joint to the distal interphalangeal (DIP) joint of the 2nd toe as well as the circumference at the center of the middle phalanx of the 2nd toe which the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) will be placed on. Data including the hemodynamic measurements from the toe and finger cuffs will be collected. Laterality of cuff placement on finger and toes will be noted. Age, gender, height, and weight of the volunteers will be recorded.
During the trials the monitors will not be visible once necessary adjustments have been made and before data collection has begun. The two data sets from each sensor (finger and toe) will be linked together at the time of data collection. The investigators will not be able to tell which volunteer the data belongs to when analyzing the data.
Prior to the placing the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA), baseline blood pressures will be taken at the start of the study from each extremity using an automatic blood pressure cuff.
The healthy volunteer will have one Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) placed on the 2nd toe and one Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) place on the index finger. The study will be performed in a break room with minimal external stimulus. The volunteer will be asked to lie supine for approximately 3 minutes until the sensors have calibrated. They will remain in the supine position for another 5 minutes for data collection. An automatic blood pressure cuff on the contralateral lower extremity to the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) will measure blood pressures at 0, 2.5, and 5 minutes. They will then be asked to perform a Valsalva maneuver at their own discretion for no longer than 5 seconds. The research protocol will be performed by the research coordinator on staff. Data collection occurs automatically every 20 seconds, but manual recording of data will be performed. The two continuous monitoring devices will be synced at the beginning of the study by simultaneously inputting a flagged event from which the start time will be inferred during data analysis.
- Conditions
- Validation, Blood Pressure, Device
- Being tested
- Continuous non-invasive blood pressure monitoring
- Keywords
- Acumen IQ cuff, continuous non-invasive blood pressure monitoring, Toe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous non-invasive blood pressure monitoringDevice
A continuous non-invasive blood pressure monitoring cuff will be placed on the volunteers index finger (as intended) and 2nd toe (primary outcome).
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy volunteers consisting of medical students and residents at our institution. Receives: Device: Continuous non-invasive blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between output from the continuous non-invasive blood pressure cuff placed on the volunteers index finger compared to the output from the continuous non-invasive blood pressure cuff placed on the volunteers 2nd toe.
The continuous non-invasive blood pressure cuff measures mean arterial pressure which will be compared between the index finger and 2nd toe of the same volunteer.
Measured: Continuous non-invasive blood pressure measurements will be collected for 10 minutes
Secondary outcomes (2)
Effects of length and circumference of the middle phalanx of the 2nd toe on the accuracy of the continuous non-invasive blood pressure cuff measurements compared to the measurements taken from the index finger.
To compare the measurements from the index finger cuff to the 2nd toe cuff based on the length and circumference of the middle phalanx of the 2nd toe.
Measured: Continuous non-invasive blood pressure measurements will be collected for 10 minutes.
Validity of the continuous non-invasive blood pressure monitoring cuff on the toe compared to automatic blood pressure cuff measurements on the contralateral lower extremity.
To compare and assess the validity of the continuous non-invasive blood pressure monitoring cuff on the 2nd toe compared to measurements taken via an automatic blood pressure cuff from the contralateral lower extremity.
Measured: Continuous non-invasive blood pressure measurements will be collected for 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start29 Jan 2025
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ValidationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riverside University Health System Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Baker, Riverside University Health System Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805435
- Sponsor's protocol ID
- 2219626-3
- Status last verified
- Feb 2025
- First submitted
- 28 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan is in place to share IPD at this time.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Continuous Non-Invasive Monitoring Accurate When Used on the Lower Extremity?: a Pilot Study
- ClinicalTrials.gov ID
- NCT06805435
- Acronym / sponsor ID
- 2219626-3
- Conditions
- Validation, Blood Pressure, Device
- Keywords
- Acumen IQ cuff, continuous non-invasive blood pressure monitoring, Toe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riverside University Health System Medical CenterUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to assess the validity of a continuous non-invasive blood pressure monitoring device, Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA), when used on the toe in healthy volunteers. The main questions it aims to answer is:
- Can a continuous non-invasive blood pressure monitoring device accurately measure hemodynamic parameters when placed on a toe as compared to the finger in a healthy volunteer?
Secondary Outcomes:
- What are the effects of length and circumference of the middle phalanx of the 2nd toe on the accuracy of the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) measurements compared to the measurements taken from the finger?
- What are the effects of a Valsalva maneuver on the measurements taken from the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) on a toe compared to the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) placed on the finger.
Participants will:
- Have blood pressures taken using an automatic blood pressure cuff (both arms and both calves)
- Have a continuous non-invasive blood pressure monitoring sensor placed on their finger and toe simultaneously for 10 minutes
- Be asked to valsalva briefly to induce a change in blood pressure to be observed by the dual sensors
Detailed description
For each volunteer the investigators will measure the length from the proximal interphalangeal (PIP) joint to the distal interphalangeal (DIP) joint of the 2nd toe as well as the circumference at the center of the middle phalanx of the 2nd toe which the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) will be placed on. Data including the hemodynamic measurements from the toe and finger cuffs will be collected. Laterality of cuff placement on finger and toes will be noted. Age, gender, height, and weight of the volunteers will be recorded.
During the trials the monitors will not be visible once necessary adjustments have been made and before data collection has begun. The two data sets from each sensor (finger and toe) will be linked together at the time of data collection. The investigators will not be able to tell which volunteer the data belongs to when analyzing the data.
Prior to the placing the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA), baseline blood pressures will be taken at the start of the study from each extremity using an automatic blood pressure cuff.
The healthy volunteer will have one Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) placed on the 2nd toe and one Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) place on the index finger. The study will be performed in a break room with minimal external stimulus. The volunteer will be asked to lie supine for approximately 3 minutes until the sensors have calibrated. They will remain in the supine position for another 5 minutes for data collection. An automatic blood pressure cuff on the contralateral lower extremity to the Acumen IQ cuff (Edwards Lifesciences LLC, Irvine, CA) will measure blood pressures at 0, 2.5, and 5 minutes. They will then be asked to perform a Valsalva maneuver at their own discretion for no longer than 5 seconds. The research protocol will be performed by the research coordinator on staff. Data collection occurs automatically every 20 seconds, but manual recording of data will be performed. The two continuous monitoring devices will be synced at the beginning of the study by simultaneously inputting a flagged event from which the start time will be inferred during data analysis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: Continuous non-invasive blood pressure monitoringHealthy volunteers consisting of medical students and residents at our institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consistent of a convenience sample of available healthy volunteer medical students or residents.
Key inclusion criteria (2 listed)
- 18 years or older
- Medical student or resident
Key exclusion criteria (2 listed)
- Medical history of Raynaud's or peripheral vascular disease
- Allergy to adhesive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous non-invasive blood pressure monitoringA continuous non-invasive blood pressure monitoring cuff will be placed on the volunteers index finger (as intended) and 2nd toe (primary outcome). | Device | Healthy volunteers |
Primary outcome
Comparison between output from the continuous non-invasive blood pressure cuff placed on the volunteers index finger compared to the output from the continuous non-invasive blood pressure cuff placed on the volunteers 2nd toe.
Time frame: Continuous non-invasive blood pressure measurements will be collected for 10 minutes
The continuous non-invasive blood pressure cuff measures mean arterial pressure which will be compared between the index finger and 2nd toe of the same volunteer.
2 secondary outcomes
Effects of length and circumference of the middle phalanx of the 2nd toe on the accuracy of the continuous non-invasive blood pressure cuff measurements compared to the measurements taken from the index finger.
Time frame: Continuous non-invasive blood pressure measurements will be collected for 10 minutes.
Validity of the continuous non-invasive blood pressure monitoring cuff on the toe compared to automatic blood pressure cuff measurements on the contralateral lower extremity.
Time frame: Continuous non-invasive blood pressure measurements will be collected for 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No. No plan is in place to share IPD at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validation and Blood Pressure, run by Riverside University Health System Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between output from the continuous non-invasive blood pressure cuff placed on the volunteers index finger compared to the output from the continuous non-invasive blood pressure cuff placed on the volunteers 2nd toe. (time frame: Continuous non-invasive blood pressure measurements will be collected for 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.